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Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00662337
First received: March 20, 2008
Last updated: September 7, 2011
Last verified: September 2011
History of Changes
  Purpose

The purpose of this study is to determine if two formulations of diphenhydramine hydrochloride are bioequivalent.


Condition Intervention Phase
Nasal Congestion
 Drug: Diphenhydramine hydrochloride
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Randomized, Two-Way Crossover Evaluation of the Bioequivalence Between Two Oral Formulations of Diphenhydramine: ULTRATAB Tablet Versus KAPSEALS Capsule

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUC0-t and AUC0-infinity [ Time Frame: At 15 minutes pre-dose (0 hour), and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 36 and 48 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety analysis included all subjects who took at least one dose of clinical trial test product and had any follow-up information. Subjects in the safety analysis set were summarized and listed, based on actual treatment received. [ Time Frame: 15 minutes pre-dose (0 hour) through 28 days post-dose ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: October 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Diphenydramine HCl
 Drug: Diphenhydramine hydrochloride
After a ten-hour fast and a one-hour fluid restriction prior to each dosing period, subjects received supervised dosing of their first 25 mg treatment with approximately eight ounces of water. Following a seven-day washout, the comparison treatment was administered according to thye same procedure.
Other Names:
  • Benadryl Allergy
  • 25 mg KAPSEALS capsule
  • 25 mg ULTRATAB tablets

Detailed Description:

Subjects were required to observe a ten-hour fast and a one-hour fluid restriction prior to each dosing period.

Subjects were randomized into one of two active treatment groups, received supervised dosing of their treatment with approximately eight ounces of water, and were required to maintain fluid restriction for one hour after treatment. Following the one-hour post-dose fluid restriction, subjects could drink water, but consumer no other food or fluids for four hours post-dose.

Following a seven-day washout period, the comparison treatment was administered according to the same procedure as above.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy male and/or female subjects between the ages of 18 and 55 years, inclusive
  • approximately 18 to 30 kg/m2 BMI
  • total body weight at least 55 kg (121 lbs)
  • able to understand and sign the written Informed Consent Form
  • willing to follow the protocol requirements and comply with protocol restrictions

Exclusion Criteria:

  • pregnant or lactating women
  • women of childbearing potential not using acceptable form of contraception 3 months prior to the first dose until completion of follow-up procedures
  • history of allergy, sensitivity, and/or idiosyncratic reaction to Benadryl, diphenhydramine hydrochloride, or diphenhydramine citrate
  • evidence of clinical, dietary or psychiatric deviation from normal that could increase the risk to the subject or research staff or interfere with the interpretation of study results
  • use of licit or illicit drugs
  • participated in any other trials within a specified number of days prior to the first dose of the trial treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662337

Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
Study Director: Melissa Israel, BS McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00662337     History of Changes
Other Study ID Numbers: A2341003
Study First Received: March 20, 2008
Last Updated: September 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Bioequivalence, diphenhydramine hydrochloride

Additional relevant MeSH terms:
Diphenhydramine
Promethazine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
 Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Sensory System Agents
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013